E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colo-rectal adenocarcinoma. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate 5-FU e 5-FDHU pharmacokinetic parameters after a test-dose administration (5-FU 250 mg/mq ev. bolus)
- To analyse possible correlations between pharmacokinetic results and adjuvant or first line treatment tolerability in colorectal cancer patients
- To exclude from fluoropyrimidine therapy patients with significant alterations of 5-FU and 5-FDHU pharmacokinetics (CL<1 l/h/mq, T1/2β>5 h, and Cmax<0.1 µg/ml, Tmax>60 min, respectively) after the administration of the 5-FU test-dose |
|
E.2.2 | Secondary objectives of the trial |
- To identify some pharmacokinetic parameters as toxicity indicators |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histological diagnosis of colon or rectum adenocarcinoma.
- Life expectation longer than 6 months.
- Proper renal functionality.
- Proper hepatic functionality.
- Proper medullary functionality.
- Radiotherapy or surgery performed since over 4 weeks.
- Patients candidate for adjuvant therapy with fluoropyrimidines alone or combined with other chemotherapeutics (oxaliplatin, irinotecan).
- Patients candidate for first line therapy with fluoropyrimidines combined with oxaliplatin and/or irinotecan and/or bevacizumab.
- Written informed consent. |
|
E.4 | Principal exclusion criteria |
- Pregnancy or breast-feeding.
- Crohns disease, ulcerous colitis or other intestinal inflammatory diseases.
- Total colectomy or ileostomy.
- Intestinal occlusion or subocclusion.
- Metabolic diseases or infections.
- Cardiac arrhythmia or ischemic cardiopathy not controlled.
- Acute myocardial infarction in the last 2 years.
- Impossibility of carrying out a suitable follow up. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- HPLC measurements of 5-FU and 5-FDHU plasma concentrations and calculation of the main pharmacokinetic parameters with the software WinNonlin 5.1 (Pharsight Corporation, USA).
- Toxicity data collection and univariate/multivariate statistical analysis of the kinetics results.
- Pharmacokinetic analysis and comparison of the results of single patients with the population previously published [Bocci et al. 2006]. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |